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FDA 510(k)

FUJIFILM Double Balloon Endoscope EI580BT

K-Number: K183032 · 2019-06-24

ApplicantFujifilm Corporation
Decision Date2019-06-24
Product CodeFDA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Double Balloon Endoscope EI580BT is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2019-06-24 under approval number K183032. The device is classified under product code FDA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJIFILM Double Balloon Endoscope EI580BT?

FUJIFILM Double Balloon Endoscope EI580BT is a medical device that received FDA 510(k) clearance on 2019-06-24. It is manufactured by Fujifilm Corporation. The 510(k) number is K183032.

When was FUJIFILM Double Balloon Endoscope EI580BT approved by the FDA?

FUJIFILM Double Balloon Endoscope EI580BT received FDA 510(k) clearance on 2019-06-24, under approval number K183032.

What company makes FUJIFILM Double Balloon Endoscope EI580BT?

FUJIFILM Double Balloon Endoscope EI580BT is manufactured by Fujifilm Corporation.

What is the FDA product code for FUJIFILM Double Balloon Endoscope EI580BT?

The FDA product code for FUJIFILM Double Balloon Endoscope EI580BT is FDA.

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Related Devices (Code: FDA)

K183683FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5Fujifilm Corporation K191330Arc EnterocuffBoddingtons Plastics, Ltd. K213195Balloon BS-3Fujifilm Corporation K231323Ancora-SBAspero Medical, Inc. K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFujifilm Corporaton K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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